Blast InjuryPhase 2NCT07131475
Precision Biomarkers to Detect Brain Injury in Active-Duty United States Special Operations Forces With Repeated Blast Exposure
A Phase 2 study testing PBR28 TSPO PET in people with Blast Injury, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This is a 4-year, longitudinal study of 100 active-duty Navy SEALs. The goal of the study is to determine whether repeated blast exposure affects SEAL brain health and to develop an initial diagnostic testing protocol that detects repeated blast brain injury. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Blast Injury
- What is being tested?
- PBR28 TSPO PET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2025to 31 Aug 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Active-duty Navy SEAL Service Member
- Early career SEAL (0-2 years) or mid-late career SEAL (10-15 years)
- Age 18-50 years
- Males, regardless of race or ethnicity
Who cannot join
- History of moderate or severe TBI
- History of major neurological disorder
- Untreated or unstable severe psychiatric condition
- Current severe medical condition that requires long-term treatment
- Any condition that may cause undue risk to the participant or create a logistical contraindication
- MRI contraindication
- PET contraindication
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brian L Edlow, MD, 617-724-6352, bedlow@mgh.harvard.edu
About this study
Official title: ReBlast Precision (Precision Biomarkers to Detect Brain Injury in Active-Duty United States Special Operations Forces With Repeated Blast Exposure)
This is a 4-year, longitudinal study of 100 active-duty Navy SEALs. The goal of the study is to determine whether repeated blast exposure affects SEAL brain health and to develop an initial diagnostic testing protocol that detects repeated blast brain injury.
Read the detailed description
Participants will travel to Massachusetts General Hospital (MGH) in Boston, MA for a 1-day study visit at enrollment (baseline) and 1-year follow-up. At each visit to MGH, participants will have brain scans, blood tests, and assessments of cognitive performance, psychological health, and physical symptoms. Every 3 months between the baseline and follow-up visits to Boston, there will be brief (~1 hour) assessments via phone or video teleconference.
- Conditions
- Blast Injury
- Being tested
- PBR28 TSPO PET
- Keywords
- repeated blast exposure, Special Operations Forces, traumatic brain injury
- Medical subject headings
- Blast Injuries, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBR28 TSPO PETDrug
Each SEAL participant will undergo brain imaging with PBR28 translocator protein (TSPO) positron emission tomography (PET) at study enrollment and at 1-year follow up.
| Study group | Role | What they receive |
|---|---|---|
| Active-duty United States Navy SEALs | Experimental | All SEAL participants will undergo comprehensive, longitudinal assessments of their exposures, cognitive performance, psychological health, physical symptoms, neuroimaging biomarkers, and blood biomarkers. Receives: Drug: PBR28 TSPO PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
neuroimaging biomarkers
TSPO tracer uptake within the brain on TSPO PET, functional connectivity of the executive control, default and salience networks on resting-state functional MRI and diffusion MRI, and brain signal abnormalities on multidimensional MRI
Measured: 1 year
blood biomarkers
tau, ptau, bd-tau, NF-L, GFAP, UCH-L1, IL-6, IL-10, TNF alpha
Measured: 1 year
neuropsychiatric symptoms
Neurobehavioral Symptom Inventory
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start14 Oct 2025
- Primary completion30 Apr 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blast InjuryStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This diagnostic study of a single group - active-duty United States Navy SEALs -will utilize PBR28 TSPO PET. Use of the PBR tracer is overseen by the U.S. FDA. Thus, this study is considered "interventional". However, given that the purpose of the study is to develop an initial diagnostic testing protocol for repeated blast brain injury, the typical Phase criteria for therapeutic trials do not apply here. We have selected "Phase 2" from the required list of choices, because the safety of the PRB tracer has been previously established (hence Phase 1 is not appropriate) and because this is not a definitive efficacy study (hence Phase 3 is not appropriate).
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Florida, Navy SEAL Foundation, National Institutes of Health (NIH), Uniformed Services University of the Health Sciences
- Responsible party
- Principal investigator, Brian L. Edlow, M.D., Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131475
- Sponsor's protocol ID
- 2025P000608
- Other IDs
- H9240525FE002
- Status last verified
- Oct 2025
- First submitted
- 24 Jul 2025
- Last updated
- 31 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: USSOCOM regulations prevent public release of the data generated for the current study. Future requests for these data may be submitted to the corresponding author and will then need to be vetted by USSOCOM.
Publications
Gilmore N, Tseng CJ, Maffei C, Tromly SL, Deary KB, McKinney IR, Kelemen JN, Healy BC, Hu CG, Ramos-Llorden G, Masood M, Cali RJ, Guo J, Belanger HG, Yao EF, Baxter T, Fischl B, Foulkes AS, Polimeni JR, Rosen BR, Perl DP, Hooker JM, Zurcher NR, Huang SY, Kimberly WT, Greve DN, Mac Donald CL, Dams-O'Connor K, Bodien YG, Edlow BL. Impact of repeated blast exposure on active-duty United States Special Operations Forces. Proc Natl Acad Sci U S A. 2024 May 7;121(19):e2313568121. doi: 10.1073/pnas.2313568121. Epub 2024 Apr 22.
PubMed 38648470
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ReBlast Precision (Precision Biomarkers to Detect Brain Injury in Active-Duty United States Special Operations Forces With Repeated Blast Exposure)
- ClinicalTrials.gov ID
- NCT07131475
- Acronym / sponsor ID
- 2025P000608
- Conditions
- Blast Injury
- Keywords
- repeated blast exposure, Special Operations Forces, traumatic brain injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- University of South Florida, Navy SEAL Foundation, National Institutes of Health (NIH), Uniformed Services University of the Health Sciences
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 4-year, longitudinal study of 100 active-duty Navy SEALs. The goal of the study is to determine whether repeated blast exposure affects SEAL brain health and to develop an initial diagnostic testing protocol that detects repeated blast brain injury.
Detailed description
Participants will travel to Massachusetts General Hospital (MGH) in Boston, MA for a 1-day study visit at enrollment (baseline) and 1-year follow-up. At each visit to MGH, participants will have brain scans, blood tests, and assessments of cognitive performance, psychological health, and physical symptoms. Every 3 months between the baseline and follow-up visits to Boston, there will be brief (~1 hour) assessments via phone or video teleconference.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This diagnostic study of a single group - active-duty United States Navy SEALs -will utilize PBR28 TSPO PET. Use of the PBR tracer is overseen by the U.S. FDA. Thus, this study is considered "interventional". However, given that the purpose of the study is to develop an initial diagnostic testing protocol for repeated blast brain injury, the typical Phase criteria for therapeutic trials do not apply here. We have selected "Phase 2" from the required list of choices, because the safety of the PRB tracer has been previously established (hence Phase 1 is not appropriate) and because this is not a definitive efficacy study (hence Phase 3 is not appropriate).
| Arm | Type | Receives |
|---|---|---|
| Active-duty United States Navy SEALs | Experimental | Drug: PBR28 TSPO PETAll SEAL participants will undergo comprehensive, longitudinal assessments of their exposures, cognitive performance, psychological health, physical symptoms, neuroimaging biomarkers, and blood biomarkers. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Active-duty Navy SEAL Service Member
- Early career SEAL (0-2 years) or mid-late career SEAL (10-15 years)
- Age 18-50 years
- Males, regardless of race or ethnicity
Key exclusion criteria (7 listed)
- History of moderate or severe TBI
- History of major neurological disorder
- Untreated or unstable severe psychiatric condition
- Current severe medical condition that requires long-term treatment
- Any condition that may cause undue risk to the participant or create a logistical contraindication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PBR28 TSPO PETEach SEAL participant will undergo brain imaging with PBR28 translocator protein (TSPO) positron emission tomography (PET) at study enrollment and at 1-year follow up. | Drug | Active-duty United States Navy SEALs |
Primary outcome
neuroimaging biomarkers
Time frame: 1 year
TSPO tracer uptake within the brain on TSPO PET, functional connectivity of the executive control, default and salience networks on resting-state functional MRI and diffusion MRI, and brain signal abnormalities on multidimensional MRI
blood biomarkers
Time frame: 1 year
tau, ptau, bd-tau, NF-L, GFAP, UCH-L1, IL-6, IL-10, TNF alpha
neuropsychiatric symptoms
Time frame: 1 year
Neurobehavioral Symptom Inventory
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2025.
- Background: PubMed 38648470Gilmore N, Tseng CJ, Maffei C, Tromly SL, Deary KB, McKinney IR, Kelemen JN, Healy BC, Hu CG, Ramos-Llorden G, Masood M, Cali RJ, Guo J, Belanger HG, Yao EF, Baxter T, Fischl B, Foulkes AS, Polimeni JR, Rosen BR, Perl DP, Hooker JM, Zurcher NR, Huang SY, Kimberly WT, Greve DN, Mac Donald CL, Dams-O'Connor K, Bodien YG, Edlow BL. Impact of repeated blast exposure on active-duty United States Special Operations Forces. Proc Natl Acad Sci U S A. 2024 May 7;121(19):e2313568121. doi: 10.1073/pnas.2313568121. Epub 2024 Apr 22.
- Individual participant dataSharing planned: No. USSOCOM regulations prevent public release of the data generated for the current study. Future requests for these data may be submitted to the corresponding author and will then need to be vetted by USSOCOM.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PBR28 TSPO PET in people with Blast Injury, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian L Edlow, M.D. (617-724-6352, bedlow@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neuroimaging biomarkers (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07131475, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2025.